FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
29737–29760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2017
AZUR CX Detachable 18 Peripheral Coil System
K162524 · KRD
MicroVention, Inc.
Cardiovascular · 175d
Cleared Mar 03, 2017
DigiX FDX
K162529 · KPR
Allengers Medical Systems Limited
Radiology · 175d
Cleared Mar 03, 2017
Z-LINKPC System
K162575 · NKG
Zavation, LLC
Orthopedic · 169d
Cleared Mar 03, 2017
Guardian Angel GA1000 Digital Vital Sign Monitoring System
K162580 · DQA
Taiwan Aulisa Medical Devices...
Anesthesiology · 169d
Cleared Mar 03, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K162646 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 162d
Cleared Mar 03, 2017
Ontex and other proprietary names
K162746 · HEB
Ontex Bvba
Obstetrics & Gynecology · 154d
Cleared Mar 03, 2017
Disposable End-to-end Anastomosis Circular Stapler
K162947 · GDW
Chongqing Qmi Surgical Co., Ltd.
General & Plastic Surgery · 133d
Cleared Mar 03, 2017
HITACHI Supria Whole-body X-ray CT System Phase 3
K163528 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 77d
Cleared Mar 03, 2017
iPulse SmoothSkin BARE Hair Removal Device
K163552 · OHT
Cyden Limited
General & Plastic Surgery · 74d
Cleared Mar 03, 2017
Inqwire Diagnostic Guide Wire
K163575 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 74d
Cleared Mar 03, 2017
TheraView TBI
K170058 · IYE
Cablon Medical B.V.
Radiology · 56d
Cleared Mar 03, 2017
3D OCT-1 Maestro
K170164 · OBO
Topcon Corporation
Ophthalmic · 44d
Cleared Mar 03, 2017
True 3D Viewer Software
K170167 · LLZ
Echopixel, Inc.
Radiology · 43d
Cleared Mar 03, 2017
ACL AcuStar
K170314 · JPA
Instrumentation Laboratory CO
Hematology · 30d
Cleared Mar 03, 2017
Cyber Ho
K170331 · GEX
Quanta System Spa
General & Plastic Surgery · 29d
Cleared Mar 03, 2017
ToeMATE® Hammertoe Correction System
K170350 · HWC
Arthrosurface, Inc.
Orthopedic · 28d
Cleared Mar 02, 2017
Dextramer CMV Kit
K153538 · GKZ
Immudex Aps
Immunology · 448d
Cleared Mar 02, 2017
Edi Catheter ENFit
K153688 · PIF
Maquet Critical Care AB
Gastroenterology & Urology · 435d
Cleared Mar 02, 2017
EndoPur Filter
K161304 · FIP
Nephros, Inc.
Gastroenterology & Urology · 296d
Cleared Mar 02, 2017
Myoject Luer Lock Needle Electrode
K161430 · IKT
Natus Manufacturing Limited
Neurology · 283d
Cleared Mar 02, 2017
ENDOFLATOR 40, ENDOFLATOR 50
K161554 · HIF
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 269d
Cleared Mar 02, 2017
REXLON, REXSIL
K161633 · GAR
Sm Eng Co., Ltd.
General & Plastic Surgery · 262d
Cleared Mar 02, 2017
RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed
K161737 · NEW
Myco Medical
General & Plastic Surgery · 252d
Cleared Mar 02, 2017
Slimming Treatment Device
K161892 · NUV
Beijing Honkon Technologies Co., Ltd.
General & Plastic Surgery · 234d